Tavneos
*Company:
Vifor Pharma UK LimitedStatus:
No Recent UpdateLegal Category:
Product subject to restricted prescription (C)Active Ingredient(s):
This medicinal product is subject to additional monitoring.
*Additional information is available within the SPC or upon request to the company
Updated on 30 January 2025
File name
Tavneos IE PIL v9_012025.pdf
Reasons for updating
- Change to warnings or special precautions for use
Updated on 30 January 2025
File name
Tavneos IE SmPC v9_012025.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
PSUR 5 including update of SmPC section 4.4 to define the monitoring frequency of hepatic transaminases and total bilirubin for the first 6 months of treatment
Updated on 16 December 2024
File name
Tavneos_EU1211605 v8 (PIL) 121224.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
Free text change information supplied by the pharmaceutical company
CCDS 2.0_RMP 2 (drug-drug interactions based on study CL020-168 (CCDS 2.0)
Updated on 16 December 2024
File name
Tavneos_EU1211605 v8 (SmPC) 121224.pdf
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
CCDS 2.0_RMP 2 (drug-drug interactions based on study CL020-168 (CCDS 2.0)
Updated on 09 August 2024
File name
Tavneos_EU1_21_1605 SmPC [07172024].pdf
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 10 - Date of revision of the text
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
- Section 6.3: shelf life extended from 3 to 4 years
- Section 10: new date of revision: 17 July 2024 (HA approval)
Updated on 09 August 2024
File name
Tavneos_EU1_21_1605 PIL [07172024].pdf
Reasons for updating
- Change to storage instructions
Free text change information supplied by the pharmaceutical company
Shelf life extended from 3 years to 4 years
Updated on 08 July 2024
File name
Tavneos_EU1211605 v6 (PIL) 062724.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 4 - possible side effects
Updated on 08 July 2024
File name
Tavneos_EU1211605 v6 (SmPC) 062724 .pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
- 4.4 - hepatotoxicity additional warning: Serious adverse reactions of elevated hepatic transaminases with elevated total bilirubin have been observed in patients receiving avacopan in combination with cyclophosphamide (followed by azathioprine or mycophenolate) or rituximab, and trimethoprim and sulfamethoxazole. In the post-marketing setting, drug-induced liver injury and vanishing bile duct syndrome (VBDS), including cases with fatal outcome, have been reported (see section 4.8).
- 4.8 - as a potential side effect with frequency not known added: Drug-induced liver injury, Vanishing bile duct syndrome.
- 10: date of revision (EMA approval); 27 June 2024
Updated on 14 November 2023
File name
Tavneos_IE_NI_PIL_311023.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 14 November 2023
File name
Tavneos_IE_NI_PIL_311023.pdf
Reasons for updating
- Change to marketing authorisation holder
Free text change information supplied by the pharmaceutical company
Deletion of OM Pharma S.A., R. da Indústria, 2 - Quinta Grande, Amadora, 2610-088, Portugal as a site responsible for importation and batch release of the finished product.
Updated on 14 November 2023
File name
Tavneos_IE_NI_PIL_311023.pdf
Reasons for updating
- Change to marketing authorisation holder
Free text change information supplied by the pharmaceutical company
Deletion of OM Pharma S.A., R. da Indústria, 2 - Quinta Grande, Amadora, 2610-088, Portugal as a site responsible for importation and batch release of the finished product.
Updated on 14 November 2023
File name
Tavneos_IE_NI_PIL_311023.pdf
Reasons for updating
- Change to marketing authorisation holder
Free text change information supplied by the pharmaceutical company
Deletion of OM Pharma S.A., R. da Indústria, 2 - Quinta Grande, Amadora, 2610-088, Portugal as a site responsible for importation and batch release of the finished product.
Updated on 14 November 2023
File name
Tavneos_IE_NI_PIL_311023.pdf
Reasons for updating
- Change to marketing authorisation holder
Free text change information supplied by the pharmaceutical company
Deletion of OM Pharma S.A., R. da Indústria, 2 - Quinta Grande, Amadora, 2610-088, Portugal as a site responsible for importation and batch release of the finished product.
Updated on 14 November 2023
File name
Tavneos_IE_NI_SmPC_311023.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Deletion of OM Pharma S.A., R. da Indústria, 2 - Quinta Grande, Amadora, 2610-088, Portugal as a site responsible for importation and batch release of the finished product.
Updated on 25 August 2023
File name
Tavneos IE_NI SPC.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 8 - Marketing authorisation number(s)
- Change to section 10 - Date of revision of the text
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
- section 4.4: units to be aligned with the one stated within section 4.2
- section 4.4: correction of immunisation safety (as there are also live bacterial vaccines such as for example Bacille Calmette-Guérin (BCG) against Tuberculosis, the MAH suggests to delete the word viral here for correctness.
- section 5.1: numbers corrected in table 3
- section 5.1: glucocorticoid toxicity: Numbers corrected
- section 8: additional MA n. EU/1/21/1605/003
- section 10: date of revision: 06/07/2023
Updated on 25 August 2023
File name
Tavneos IE_NI PIL.pdf
Reasons for updating
- Change to date of revision
Updated on 09 December 2022
File name
Avacopan IE SPC December 2022.pdf
Reasons for updating
- Introduction of new pack/pack size
Legal category:Product subject to restricted prescription (C)
Updated on 09 December 2022
File name
Avacopan IE PIL December 2022.pdf
Reasons for updating
- Introduction of new pack/pack size
Updated on 09 August 2022
File name
Avacopan IE PIL March 2022.pdf
Reasons for updating
- Correction of spelling/typing errors
Updated on 17 May 2022
File name
Avacopan IE PIL March 2022.pdf
Reasons for updating
- Change to further information section
Updated on 08 March 2022
File name
Avacopan IE PIL March 2022.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
New first approved PIL for Ireland
Updated on 08 March 2022
File name
Avacopan IE SPC March 2022.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
New first approved SPC for Ireland
Vifor Pharma UK Limited
Address:
Point, 29 Market Street, Maidenhead, SL6 8AA, United KingdomMedical Information E-mail:
MedicalInfo_UK@viforpharma.comTelephone:
+44 (0)1276 853 600Fax:
+44 (0)1276 452 341Medical Information Direct Line:
+44 (0)1276 853 633Customer Care direct line:
+44 (0)1276 853 633